Diaper product adapted for collection of exudate sample from an infant

ABSTRACT

Diapers adapted for use in the collection of stool samples from infants are disclosed. Such diapers may include a backsheet comprising an effectively liquid impermeable material, a transverse perineal barrier comprising an effectively liquid impermeable material and sealingly connected to another component of the diaper, and a liquid control structure disposed over the backsheet and forward of the transverse perineal barrier. The diaper may include other features adapted to contain exudates, isolate urine from fecal material following discharge, avoid absorption of liquid components of fecal material and enhance likelihood of collecting a fecal sample that is sufficiently representative of its composition immediately following discharge.

CROSS REFERENCE TO RELATED APPLICATION

This application claims the benefit of U.S. Provisional PatentApplication No. 62/525,246, filed on Jun. 27, 2017, the entiredisclosure of which is fully incorporated herein by reference.

BACKGROUND

Collection of urine samples from infants is sometimes desired formedical diagnostic or research purposes, for example, to identify orstudy characteristics or effects of medical conditions such asinfections, allergies, presence of drugs in the infants' systems, orother conditions. Urine can be tested to yield information relating tokidney function, electrolyte balance and some illnesses and infections.Testing for the presence of drugs in newborn babies is increasinglydesired, as problems associated with maternal drug abuse are comingunder greater scrutiny; analysis of urine samples is a commonly usedtesting method. Typically in such circumstances it is desired to obtaina sample that is free of contamination by fecal matter or othersubstances that may contact the urine after urination. It is alsotypically desired that the urine sample is intact, in that quantities orwater or other constituents have not been removed by, e.g., evaporationor absorption into, e.g., absorbent components of a diaper.

Similarly, collection of stool samples from infants is sometimes desiredfor medical diagnostic or research purposes, for example, to identify orstudy characteristics or effects of medical conditions such asinfections, allergies or other conditions. Typically in suchcircumstances it is desired to obtain a stool sample that isuncontaminated and intact, i.e., has not been contaminated by urine orany other substance, and has not had any of its constituents removed by,e.g., absorption into a diaper.

Particularly in young infants, urination is usually not sufficientlypredictable to provide warning or time for a caregiver to prepare tocollect an uncontaminated and intact sample at the time urinationoccurs. Similarly, a bowel movement is usually not sufficientlypredictable to provide warning or time for a caregiver to prepare tocollect an uncontaminated and intact stool sample immediately afterelimination occurs. An attempt at collection some period of time afterelimination substantially increases the risk that the sample will benon-representative. Additionally, it may be undesirable to allow fecalmaterial to be in contact with relatively sensitive and/or delicate skinof very young infants, to any substantial extent or for any substantialperiod of time.

There are currently various devices and methods that that have beenadopted by health care professionals to collect urine samples. Thesehave included inserting extra absorbent material (such as cottonwadding) into a diaper proximate the discharge location; following aurine discharge, the material may be removed from the diaper andcompressed to expel the absorbed urine into a sample container. Othermethods have involved use of catheters (internal and external). Thesemethods have not been entirely satisfactory; they have been deemedoverly cumbersome, messy, or undesirably uncomfortable and/or invasivefor the infant patient.

Anticipatory methods and devices for stool sample collection used todate, also, have included undesirably invasive devices and steps, e.g.,use of catheters or bag devices, or have been deemed difficult, messy,hazardous and/or unreliable. Additionally, devices such as bag deviceshave often involved use of adhesive to affix them to the patient's skin.Particularly for premature and very young infants this may beunsatisfactory because these patients typically have very sensitive anddelicate skin, which can be painfully irritated and even damaged by useof adhesives.

Currently available disposable absorbent diapers are not satisfactoryfor collecting uncontaminated and intact urine samples, because they donot isolate urine from fecal matter; they absorb aqueous liquidrelatively quickly and do not readily release it; and they often includematerials that can contaminate a urine sample and/or otherwise render itnon-representative of its composition immediately following urination.

Similarly, disposable diapers of conventional design are unsuitable asstool sample collection devices because they are designed to rapidlyabsorb and retain liquid exudates in an absorbent structure. Any stoolin a conventional diaper that remains unabsorbed upon removal of thediaper from the infant will have had much of its liquid content removedby absorption into the absorbent structure, rendering itnon-representative of its original composition.

Therefore, there is room for improvement to methods and/or devices bywhich uncontaminated and intact urine and/or stool samples may becollected from infants for purposes of medical diagnosis, research, etc.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a perspective view of a diaper in a relaxed, opened positionas it might appear resting on a table, wearing-facing side up.

FIG. 2A is a plan view of a diaper in an extended and flat condition,with the wearer-facing surfaces facing the viewer.

FIG. 2B is a plan view of another example of a diaper in an extended andflat condition, with the wearer-facing surfaces facing the viewer.

FIG. 3A is a plan view of a diaper in an extended and flat condition,with the outward-facing surfaces facing the viewer.

FIG. 3B is a plan view of another example of a diaper in an extended andflat condition, with the outward-facing surfaces facing the viewer.

FIG. 4A is a schematic, exploded longitudinal cross-section of oneexample of a diaper as shown in FIG. 2A, taken along line 4-4 shown inFIG. 2A.

FIG. 4B is a schematic, exploded longitudinal cross-section of anotherexample of a diaper as shown in FIG. 2A, taken along line 4-4 shown inFIG. 2A.

FIG. 4C is a schematic, exploded longitudinal cross-section of oneexample of a diaper as shown in FIG. 2B, taken along line 4-4 shown inFIG. 2B.

FIG. 4D is a schematic, exploded longitudinal cross-section of anotherexample of a diaper as shown in FIG. 2B, taken along line 4-4 shown inFIG. 2B.

FIG. 4E is a schematic, exploded longitudinal cross-section of anotherexample of a diaper as shown in FIG. 2B, taken along line 4-4 shown inFIG. 2B.

FIG. 5 is a schematic, exploded lateral cross-section of one example ofa diaper as shown in FIG. 2, taken along line 5-5 shown in FIG. 2A.

FIG. 6A is a schematic, exploded lateral cross-section of one example ofa diaper as shown in FIG. 2A, taken along line 6-6 shown in FIG. 2A.

FIG. 6B is a schematic, exploded lateral cross-section of anotherexample of a diaper as shown in FIG. 2B, taken along line 6-6 shown inFIG. 2B.

FIG. 7 is a plan view of another example of a diaper in an extended andflat condition, with the wearer-facing surfaces facing the viewer.

FIG. 8 is a schematic, exploded lateral cross-section of a diaper asshown in FIG. 7, taken along line 8-8 shown in FIG. 7.

FIG. 9 is a perspective view of a diaper in a relaxed, opened positionas it might appear resting on a table, wearing-facing side up.

FIG. 10A is a plan view of a diaper in an extended and flat condition,with wearer-facing surfaces facing the viewer.

FIG. 10B is a plan view of another example of a diaper in an extendedand flat condition, with wearer-facing surfaces facing the viewer.

FIG. 11 is a plan view of a diaper in an extended and flat condition,with outward-facing surfaces facing the viewer.

FIG. 12 is a schematic, exploded longitudinal cross-section of oneexample of an example of a diaper as shown in FIG. 10A, taken along line12-12 shown in FIG. 10A.

FIG. 13A is a schematic, exploded lateral cross-section of a diaper asshown in FIG. 10A, taken along line 13A-13A shown in FIG. 10A.

FIG. 13B is a schematic, exploded lateral cross-section of a diaper asshown in FIG. 10B, taken along line 13B-13B shown in FIG. 10B.

FIG. 14A is a schematic, exploded lateral cross-section of one exampleof the diaper shown in FIG. 10A, taken along line 14-14 shown in FIG.10A and depicting such portion of the diaper stretched out laterallyagainst any lateral contraction of included pre-strained elasticmembers.

FIG. 14B is a schematic, exploded lateral cross-section of one exampleof diaper shown in FIG. 10A, taken along line 14-14 shown in FIG. 10Aand depicting such portion of the diaper laterally contracted as mightoccur with the presence of included laterally pre-strained elasticmembers.

FIG. 15 is an enlarged schematic, perspective depiction of a portion ofan apertured film topsheet, with apertures defined by funnel structures.

FIG. 16 is an enlarged schematic depiction of a cross section of portionof an apertured film topsheet, taken through a funnel structure.

FIG. 17A is an enlarged view of a portion of the cross section indicatedin circled region 17, in FIG. 12, in one example.

FIG. 17B is an enlarged view of a portion of the cross section indicatedin circled region 17, in FIG. 12, in another example.

FIG. 18 is a plan view of an example of a stool sample receptacle.

FIGS. 19A-19E are plan views of examples of stool gates.

DESCRIPTION OF EXAMPLES Definitions

The term “hydrophilic” describes surfaces such as film or fibersurfaces, which are wettable by aqueous fluids (e.g., aqueous bodyfluids) deposited on these fibers. Hydrophilicity and wettability aretypically defined in terms of contact angle and the strike through timeof the fluids, for example through a nonwoven fabric. This is discussedin detail in the American Chemical Society publication entitled “Contactangle, wettability and adhesion”, edited by Robert F. Gould (Copyright1964). A fiber or surface of a fiber is said to be wetted by a fluid(i.e., hydrophilic) when either the contact angle between the fluid andthe fiber, or its surface, is less than 90°, or when the fluid tends tospread spontaneously across the surface of the fiber, both conditionsare normally co-existing. Conversely, a fiber or surface of the fiber isconsidered to be hydrophobic/non-wettable if the contact angle isgreater than 90° and the fluid does not spread spontaneously across thesurface of the fiber.

The “liquid control structure” of a diaper includes all components andstructure overlying a liquid impermeable backsheet, and disposed alongand straddling the longitudinal axis of the diaper, except for a liquidpermeable topsheet. If the diaper includes a topsheet, the liquidcontrol structure includes all components and structure disposed betweenthe backsheet and the topsheet, and disposed along and straddling thelongitudinal axis of the diaper. An absorbent core structure astypically appears in currently marketed disposable diapers is one typeof “liquid control structure” as the latter term is used herein;however, a “liquid control structure” as the term is more broadly usedherein may retainably absorb aqueous liquid, as will an absorbent corestructure of a typical diaper, or may, alternatively, be adapted not to,or have a portion adapted not to, retainably absorb aqueous liquid inportions or in the entirety thereof. The liquid control structure of adiaper has a plan surface area when the diaper is laid out in extendedand flat configuration on a horizontal surface, viewed from above alonga direction orthogonal to the surface. The plan surface area alsodefines a volume of space, coextensive with the plan surface area in thex-y plane and quantified by the plan surface area and the averagez-direction caliper or thickness of the liquid control structure.

“Lateral,” “transverse,” and forms thereof, with respect to a diaper ora component thereof, refers to a direction generally parallel to thewaist edges of the diaper.

“Length,” with respect to a diaper or a component thereof, refers to adimension measured along a direction generally perpendicular to thewaist edges of the diaper.

“Longitudinal,” and forms thereof, with respect to a diaper or acomponent thereof, refers to a direction generally perpendicular to thewaist edges of the diaper.

“Width,” with respect to a diaper or a component thereof, refers to adimension measured along a direction generally parallel to the waistedges of the diaper.

“Liquid impermeable,” with respect to a sheet or layer component of adiaper positioned to receive urine or fecal exudate, means that liquidcomponents of the exudate will not pass through the sheet or layer fromone side to the other, without application of an amount of pressure,exceeding atmospheric level, to the liquid as it contacts the sheet orlayer. A liquid impermeable sheet or layer of material may be formed ofa continuous, unapertured and non-porous polymer film; or a polymer filmwith apertures or pores that are sufficiently small in combination withsufficient hydrophobic surface properties of the polymer such that theliquid will not pass through the apertures or pores without applicationof pressure; or a fibrous nonwoven web material having a combination ofsufficiently small interstitial/interfiber spaces or pores andsufficient hydrophobic surface properties of the fibers such that theliquid will not pass through the apertures or pores without applicationof pressure. An apertured or porous sheet or layer of material may beliquid impermeable as defined above, but may be permeable to watervapor.

“Liquid permeable,” with respect to a sheet or layer component of adiaper positioned to receive urine or fecal exudate, means that liquidcomponents of the exudate will pass through the sheet or layer from oneside to the other, without application of an amount of pressure,exceeding atmospheric level, to the liquid as it contacts the sheet orlayer. A liquid permeable sheet or layer of material may be formed of apolymer film, having apertures or pores that are sufficiently large,and/or having sufficiently hydrophilic surface properties, such that theliquid will pass through the apertures or pores without application ofpressure. A liquid permeable sheet or layer of material may be formed ofa fibrous nonwoven web material, having sufficiently large apertures,interstitial/interfiber spaces or pores, and/or having sufficientlyhydrophilic surface properties of the fibers, such that the liquid willpass through the apertures or interstitial/interfiber spaces or poreswithout application of pressure.

A “nonwoven” web material is a manufactured web of directionally orrandomly oriented fibers consolidated into a web and bonded by friction,entanglement, thermal bonding, mechanical bonding, cohesion and/oradhesion, or any combination thereof. The term excludes film, paper andproducts which are woven, knitted or stitch-bonded. The fibers may be ofnatural or man-made (synthetic) origin. They may be staple fibers orcontinuous fibers. Nonwoven fabrics can be formed by processes such asbut not limited to meltblowing, spunbonding, dry-laying, wet-laying andcarding, and combinations thereof. The basis weight of nonwoven webmaterials is usually expressed in grams per square meter (gsm).

“Inboard” and “outboard” are relative terms relating the locations oftwo features of a diaper with respect to a longitudinal axis of thediaper. A first feature of a diaper is inboard of a second feature ofthe diaper, and the second feature is outboard of the first feature,when the first feature lies closer to the longitudinal axis of thediaper than the second feature.

“Underlie” and “overlie” (and forms thereof) refer to a verticalpositional relationship between two components of a diaper that is open,extended and laid out flat on a horizontal surface with thewearer-facing surfaces facing up. With the diaper in this position, afirst component overlies a second component, and the second componentunderlies the first component, when the first component lies directly orindirectly over or on top of the second component, or the secondcomponent lies directly or indirectly beneath the first component.

The terms “upper” and “lower,” and forms thereof, used with respect tocomponents of a diaper, relate to the vertical direction and positioningof the components when the diaper is open, extended and laid out flat ona horizontal surface with the wearer-facing surfaces facing up. Withrespect to FIGS. 5, 6A, 6B, 8, 13A, 13B, 14A and 14B, the uppermostcomponents are depicted nearest the top of the page and the lowermostcomponents are nearest the bottom of the page.

“Wearer-facing,” with respect to a diaper or a component thereof, meansthe side of the diaper or component that faces the wearer's body whenthe diaper is worn in its normal configuration, with the backsheet tothe outside. “Outward-facing” means the side of the diaper or componentthat faces away from the wearer when the diaper is worn in its normalconfiguration. In FIGS. 4A-4D, the wearer-facing side of each componentis depicted to the left, and the outward-facing side of each componentis depicted to the right. In FIGS. 5, 6A, 6B and 8, the wearer-facingside of each component is depicted toward the top of each figure, andthe outward-facing side is toward the bottom. In FIG. 12, thewearer-facing side of each component depicted is to the left, and theoutward-facing side of each component is to the right. In FIGS. 13A,13B, 14A and 14B, the wearer-facing side of each component depicted istoward the top of each figure, and the outward-facing side is toward thebottom.

“x-y plane”, used with respect to a diaper, relates to a plane parallelto a horizontal surface upon which the diaper may be opened, extendedand laid out flat with the wearer-facing surfaces facing up. Withrespect to FIGS. 2A, 2B, 3A, 3B, 7, 10A, 10B and 11, the plane of thepage is an x-y plane.

“z-direction,” used with respect to a diaper, relates to the directionorthogonal to the x-y plane. With respect to FIGS. 2A, 2B, 3A, 3B, 7,10A, 10B and 11, the z-direction is the direction orthogonal to theplane of the page.

Examples of Features That May Be Useful for Diapers for Purposes Herein

Referring generally to FIGS. 1, 2A, 3A, 4A, 9, 10A and 12, a diaper 10may have an outward-facing backsheet 14 and a wearer-facing topsheet 16.Backsheet 14 and topsheet 16 may be affixed together either directly, orwith other layers interposed therebetween, to form an enveloped spacetherebetween. In one example, backsheet 14 and topsheet 16 may beaffixed together partially or entirely about their peripheries bydeposits of adhesive 54.

Fastening System

Diaper 10 may including a pair of fastening members 50 extendinglaterally outboard of the main structure in the rear portion 11.Fastening members 50 may be integral and/or contiguous with othercomponents forming the diaper (such as the backsheet and/or topsheet),or may be separately formed and attached via bonds 53 as suggested inFIGS. 2A, 3A, 10A, 10B and 11. Fastening members 50 may be formed of anonwoven web material, a polymer film material (which may beelastomeric), a laterally elastically stretchable stretch laminatematerial, or any other web/sheet material having lateral tensilestrength suitable for sustaining lateral tensile forces present when thediaper is fastened about an intended wearer. Each fastening member mayhave affixed thereon a fastening component 51 such as a patch of hooks,forming a component of a hook-and loop fastening system; alternatively,fastening component 51 may be a patch of material bearing adhesive, orany other suitable fastening mechanism. A corresponding receivingmaterial such as patch of loops material or adherent material thateffectively contacts and fastenably attaches to the adhesive-bearingmaterial may be included on the outer side of front portion 12 of thediaper at a landing zone 52. It will be appreciated that other types offastening components and fastening systems are known and may be used asan alternative to a hook-and-loop or adhesive fastening system.

Backsheet

Diaper 10 may have an outer backsheet 14 that forms most of theoutward-facing surfaces of the diaper when worn. Backsheet 14 may beliquid impermeable and may be formed of a single layer of material ormay be formed of a laminate of two or more layers of material. In oneexample, backsheet 14 may be formed of an inner layer of an effectivelyliquid impermeable polymeric film, laminated with an outer layer of anonwoven web material. An outer layer of nonwoven material may beincluded for purposes of enhancing tensile strength of the backsheetand/or for imparting a softer, more cloth-like feel and appearance tothe backsheet. In another example, an effectively liquid impermeablebacksheet may be formed of a nonwoven web material alone, having atleast a layer of closely-spaced, fine fibers such as meltblown fibersthat are hydrophilic, e.g., in a spunbond-meltblown-spunbond (SMS)layered configuration. In a simpler example, backsheet 14 may be formedof a layer of polymeric film alone.

In conventional disposable diapers, it is often desired that thebacksheet have high opacity, for aesthetic purposes of concealment ofthe presence of exudates contained in the diaper during wear. However,for the special purposes contemplated herein, i.e., timely collection ofexudates samples, it may be desired that the backsheet have sufficienttranslucency or even transparency, and in some examples colorneutrality, to enable easy visual detection of the presence of stooland/or urine therein.

Manipulation of opacity (conversely, translucency) by selection ofmaterial components, opacifying additives, and manufacturing techniquesis well known in the art. For purposes of decreasing opacity/increasingtranslucency, opacifying and/or whitening additives (such as, forexample, TiO2), and/or coloring agents (i.e. dyes, pigments) may beminimized or even omitted entirely from the materials constituting thebacksheet. Clarifying additives may be included in the resinformulations used to form the backsheet materials, e.g., backsheet filmand/or nonwoven fibers. For purposes described above, it may be desiredthat the backsheet have an opacity no greater than 50 percent, morepreferably no greater than 45 percent, even more preferably no greaterthan 40 percent, and still more preferably no greater than 35 percent,as measured by the opacity test method described below.

Longitudinal Cuffs

Diaper 10 may include a pair of standing longitudinal cuffs 18. Suchcuffs are currently common in disposable diapers and are variously knownas gasketing cuffs, standing cuffs, barrier cuffs, etc. Longitudinalcuffs 18 may be formed of a fibrous nonwoven material, a polymeric filmmaterial, or a laminate thereof. In one example, longitudinal cuffs 18may be formed of an effectively liquid impermeable material, which willserve to prevent escape of liquid constituents of stool collected in thediaper. Non-limiting examples of suitable materials for forminglongitudinal cuffs are described in U.S. Pat. No. 7,695,463.

As reflected in FIGS. 5, 6A, 6B, 13A and 13B, longitudinal cuffs 18 mayeach have a proximal portion 21 affixed to an underlying component ofthe diaper structure such as a topsheet and/or backsheet, and a freelongitudinal distal edge 20. Each cuff 18 may be longitudinally affixedalong the proximal portion 21 to the diaper structure by mechanical orthermal bonding, by adhesive or other means, or a combination thereof,however, use of adhesive to bond or supplementally bond proximalportions 21 to the structure may serve to provide a liquid seal at thejunction between the cuff 18 and the underlying component. In oneexample, the proximal portion 21 of the cuff 18 is bonded to thetopsheet 16, 16 f and/or 16 r with a continuous application of adhesivetherebetween, to provide a liquid seal at the junction. The adhesive maybe a hot-melt type adhesive conventionally used in the manufacture ofdisposable diapers.

As may be appreciated from FIG. 2A and 10A, the material forminglongitudinal cuffs 18 and the free distal edges 20 thereof mayadditionally be bonded to the diaper structure at cuff edge/end bonds22. In combination, cuffs 18 may each include one or more longitudinalcuff elastic members 19 proximate the free longitudinal distal edges 20.During manufacturing, longitudinal cuff elastic members 19 may beincorporated and affixed into the cuff 18 structures in a pre-strainedcondition. Upon completion of manufacturing, release from themanufacturing line, and relaxation of the diaper structure, the elasticmembers 19 longitudinally contract toward their unstrained lengths,causing the free edges 20 to pull longitudinally against the cuffend/edge bonds 22, thereby causing the diaper 10 structure to curltoward the wearer-facing side as suggested in FIGS. 1 and 9, and causingthe free edges 20 of the cuffs to pull away from the structure and thecuffs to “stand.” This feature causes the free edges 20 of the cuffs toextend toward and draw against the wearer's skin along the buttocks andthrough the crotch region, when the diaper is worn, thereby performing agasketing function that serves to contain exudates between the cuffs 18.

This combination of cuff end/edge bonds 22 and pre-strained longitudinalcuff elastic members 19 can cause the cuffs 18 to stand as describedabove regardless of whether the edges 20 and end/edge bonds 22 aredisposed inboard, or outboard, of the affixed proximal portions 21 ofthe cuffs. In the examples depicted in FIGS. 2A, 2B, 4, 5, 10A and 13A,it can be appreciated that the location of end/edge bonds 22 relativeaffixed proximal portions 21 causes the free edges 20 of cuffs 18, whilestanding, to be drawn by contraction of elastic members 19 toward thecenter of the diaper (i.e., toward longitudinal axis 4-4). This maycause free edges 20 to tend to rest against areas of the wearer's crotchregion closer to the longitudinal center of the diaper when the diaperis worn. In another example, however, cuffs 18 may be constructed suchthat end/edge bonds 22 are disposed outboard of the affixed proximalportions of the cuffs 18, such that free edges 20 of cuffs 18 are drawnby contraction of elastic members 19 away from the longitudinal axis4-4, i.e., toward more outboard regions of the diaper. This may causefree edges 20 of cuffs 18 to tend to rest against the wearer's skin inlocations more laterally removed from central areas in the wearer'scrotch region, e.g., against the inward-facing surfaces of the buttocksin the gluteal cleft, and against the inner thighs in the crotch region.Better gasketing and better liquid containment may occur with one or theother configuration depending upon wearer size, position and activitylevel, and thus one or the other configuration may be preferred undergiven circumstances. Other non-limiting examples of suitablelongitudinal cuff construction are described in U.S. Pat. No. 7,794,441.

Elastic members 19 may be discontinuously or continuously adhered alongtheir lengths to the material(s) forming cuff 18 structures by, e.g.,adhesive applied by strand-coating the elastic members. In some examplesthe material forming the cuffs 18 may be folded over the elastic members19 to better contain them and restrain them within the cuff structure inthe event of failure of the adhesive. This has the further advantage ofproviding a folded (rather than cut) material edge as distal edge 20,providing a neat appearance and softer feel.

In some examples it may be desired that rear topsheet 16 r andlongitudinal cuffs 18 are continuously integrally joined where theymeet, thereby preventing escape of liquid at the junction therebetween.In one example suggested in FIG. 6A, an effectively liquid impervioussheet or web material (such as a polymer film) forming rear topsheet 16r in whole or in part may contiguously form a portion or layer of eachlongitudinal cuff 18 in the rear portion of the diaper. In one example,an effectively liquid impermeable sheet or web material (such as apolymer film) forming topsheet 16, 16 f and or 16 f in whole or in partmay contiguously form a portion or layer of each longitudinal cuff 18.The impermeable topsheet material can be imparted with a pattern ofapertures to render it liquid permeable in a zone or region overlying anabsorbent core and/or liquid control structure 15.

In simplified examples made more apparent in FIGS. 7, 8, 10B and 13B,longitudinal outer cuffs 18 a may be formed by an alternative and/oradditional configuration by portion(s) of the material of the topsheet16, 16 f, 16 r and/or backsheet 14 extending laterally beyond the liquidcontrol structure 15, with attached, sandwiched, enveloped or otherwisecaptured outer cuff elastic members 19 a. Outer cuff elastic members 19a may also be incorporated into the structure while in a pre-strainedcondition as described above. Upon completion of manufacturing, releasefrom the manufacturing line, and relaxation of the diaper structure, theelastic members 19 a longitudinally contract toward their unstrainedlengths, causing the free edges 20 a to pull longitudinally, therebycausing the diaper 10 structure to curl toward the wearer-facing side assuggested in FIGS. 1 and 9, and causing the free edges 20 a of the cuffsto lift up from the structure and the outer cuffs to “stand”. Thisfeature causes the free edges 20 a of the outer cuffs to draw againstthe wearer's skin along the inner thighs and buttocks, when the diaperis worn, thereby performing a gasketing function that serves to containexudates within the diaper.

In another example apparent in FIGS. 1, 2A, 5, 6A, 9, 10A and 13A, adiaper may be configured with two pairs of longitudinal cuffs,longitudinal cuffs 18, and outer longitudinal outer cuffs 18 a.

Exudates Indicator

It may be desired that the diaper 10 include a wetness indicator 40(see, e.g., FIGS. 3A-6A and 11-13B) that imparts a visible change ofappearance to the diaper on the outside, when liquid exudate(s) has(have) entered the space containing the absorbent core and/or liquidcontrol structure. This can help notify the caregiver that a dischargeof exudate(s) has occurred, and thereby promote a prompt removal of thediaper from the patient to, for example, reduce the chances that theinfant's skin will be irritated by exudates, that a stool sample will becontaminated by urine that may escape into the space in the rear portionadapted for receiving the stool sample (or vice versa), and/orfacilitate prompt sample collection.

The wetness indicator may have any form, composition or configurationsuitable for a relatively prompt response. In one example, a wetnessindicator may include a material applied or affixed to the wearer-facingsurface of the backsheet 14, in the envelope space between the topsheetand the backsheet where exudate will be received. In another example, awetness indicator may include an indicator material applied or affixedto an outward-facing surface of the liquid control structure 15 and/orliquid control structure 35. The indicator material may include acomposition selected, formulated and/or adapted to visibly changeappearance when wetted, or when warmed by contact with recentlydischarged exudate. The appearance change may be one or more of a changein color, an appearance or disappearance of a visible element, or anyother visible change that occurs when the composition is wetted orwarmed. The material(s) forming liquid impermeable backsheet 14 may beselected to have sufficient translucence (e.g., sufficiently lowopacity) to enable effectively clear visibility of the wetness indicatoron the outside of the diaper, in combination with the materials,composition, configuration and placement location of the wetnessindicator 40. Non-limiting suitable examples are described in pendingU.S. provisional applications Ser. Nos. 62/147,258 and 62/186,406. Othernon-limiting suitable examples are described in U.S. Pat. Nos.8,927,801; 8,618,349; 7,332,642; 7,159,532; 6,075,178; and 4,231,370;and U.S. published application nos. 2015/173968; 2013/116644;2011/137274; and 2004/0254549.

In other examples, an included wetness indicator may operate toelectrically/electronically trigger a visible and/or audible signal whenthe diaper is wetted. In some examples, a combination of a sensingdevice or devices included in components of the diaper that will beexposed to wetness, and a signal-receiving/processing device, may beincluded. In such examples, the sensing device in the diaper generates asignal indicative of a wetted condition, and thesignal-receiving/processing device receives the signal and provides avisible and/or audible signal to the caregiver. In some examples, thesignal-receiving/processing device may be remote from the diaper and maybe carried about by the caregiver. Non-limiting examples are describedin U.S. Pat. Nos. 9,241,839 and 6,603,403; and U.S. Pat. App. Pub. Nos.2010/0030173 and 2010/0164733. Various improvements and variations ofsuch examples as well as other configurations of diaper wetnessdetection devices are described and known in the art.

In still other examples, it may be desired that the diaper include adevice adapted to detect, and cause generation of a visible and/oraudible signal of, the presence of stool in the diaper. This may provideanother means of facilitating the prompt retrieval of an unadulteratedstool sample. Non-limiting examples are described in U.S. Pat. No.8,933,292.

Examples of Features for Stool Sample Collection

FIGS. 1-8 depict various features that may be embodied in a diaper 10.Diaper 10 may have a rear portion 11, front portion 12 and perinealportion 13 between the front portion and rear portion. For reference,the lateral width of diaper 10 may be equally divided by an imaginarylongitudinal axis 4-4 (FIG. 2A).

Front and Rear Topsheets

Diaper 10 may include a liquid control structure 15 adapted to receive,absorb and retain liquid exudates (e.g., urine). As may be seen in FIGS.4A-6, liquid control structure 15 may be disposed in the diaper betweenbacksheet 14, and a front topsheet 16 f in the front portion 12, and arear topsheet 16 r in the rear portion 11.

The front topsheet 16 f may be formed of a liquid permeable material,for example, a nonwoven material such as described in U.S. Pat. No.8,968,614. For purposes of ensuring rapid passage of urine through thefront topsheet 16 f to the materials of the liquid control structure 15,thereby minimizing chances of contamination of a stool sample withurine, it may be desired that the front topsheet 16 f be formed of anapertured nonwoven material formed of fibers. The fiber constituents maybe selected or manufactured to be inherently hydrophilic, or may betreated, e.g., with an application of a surfactant, to imparthydrophilic surface properties. Suitable examples of apertured topsheetsare described in U.S. Pat. Nos. 7,033,340; 6,680,422; 6,498,284;6,414,215; 5,516,572; and 5,342,338; and in pending U.S. applicationSer. No. 14/270,468.

The rear topsheet 16 r may be formed of an effectively liquidimpermeable material that hinders or blocks passage of liquidconstituents therethrough. In one example, rear topsheet 16 r may beformed of a polymeric film. In another example, rear topsheet 16 r maybe formed of an effectively liquid impermeable nonwoven web material. Anexample of such material is disclosed in, for example, U.S. Pat. App.Pub. No. 2006/0014460.

For purposes of simplification of manufacturing, it may be desired thatthe material forming a liquid permeable front topsheet 16 f extends tothe rear portion of the diaper, or even the full length of the diaper10. This eliminates the need for special cutting and/or material bondingsteps that would be associated with including a foreshortened fronttopsheet 16 f, i.e., one that does not extend the full length of thediaper. If a full-length front topsheet 16 f is included, it may besimply overlaid by the effectively liquid-impermeable rear topsheet 16r.

In another example, one contiguous sheet of material may be used to formboth front topsheet 16 f and rear topsheet 16 r. The material maymanufactured or treated to be effectively liquid permeable in the frontportion 12 and effectively liquid impermeable in the rear portion 11. Inone particular example, an effectively liquid impermeable material mayform a single contiguous layer constituting both front topsheet 16 f andrear topsheet 16 r, but the material may be subjected to an aperturingprocess that forms apertures in the front portion, making the fronttopsheet 16 f portion effectively liquid permeable. In anotherparticular example, an effectively liquid permeable material may form asingle contiguous layer constituting both front topsheet 16 f and reartopsheet 16 r, but the material may be subjected to a process renderingit effectively liquid impermeable in the rear portion. Suitableprocesses may include applying a film layer to the rear portion;applying a melted hydrophilic polymer composition to the rear portion bymethods such as slot coating or roller techniques such as used inprinting; spraying a hydrophilic coating material (such as, for example,a wax) over the material of the rear portion, etc.

In another simpler example, the rear topsheet 16 r and the backsheet 14may be integral and/or unitary in the rear portion of the diaper, behindthe transverse perineal barrier 23 (described below). In other words, asingle, effectively liquid impermeable web member or a single,effectively liquid impermeable multi-layer laminate, may form both theoutward-facing surface of the diaper and the wearer-facing surface ofthe diaper, in the rear portion of the diaper, with no separateintermediate layer. In such example, the components of the liquidcontrol structure may be disposed only in the portion of the diaperforward of the transverse perineal barrier 23. This example isillustrated schematically in FIG. 4B.

Pass-Through Port and Stool Sample Receptacle

It may be appreciated that a close-fitting diaper may have limitedvolume available in the rear region for receipt, containment andnon-absorptive storage of discharged stool prior to the time the diaperis removed for sample retrieval. In some circumstances it may beexpected that the infant patient may discharge a volume of stool that islarger than a close-fitting diaper has capacity to receive and contain.In some circumstances it may be desired that the discharged stoolcontact the infant patient's skin as little as possible. In suchcircumstances and others, it may be desired that the diaper be impartedwith a structure providing greater volume capacity.

Thus, referring to FIGS. 2B, 3B, 4C, 4D and 6B, in some examples, thediaper may be provided with a pass-through port 60, positioned generallyin the perineal portion or crotch region 13 and/or the rear portion orrear region 11 of the diaper, proximate the expected wearer's anus,which will allow stool exudate to pass entirely through the diaper tothe outside thereof. The pass-through port 60 may be accompanied by asample collection receptacle 61, suitably sealingly affixed about theperimeter of the port 60 so as to prevent leakage of stool exudate outof the diaper. Collection receptacle 61 may have any suitable form,structure and composition. In some examples, collection receptacle 61may be a bag structure, having an open end and a closed end, formed ofliquid impermeable polymeric film. In some examples receptacle 61 may beprovided with a rolled, folded, pleated or similar configuration, and/orstretch capability, that allows it to expand and/or increase incontainment volume with a discharge of exudate thereinto. The diaper maybe provided initially (i.e., as packaged) with the receptacle in asubstantially collapsed condition, such that its available containmentvolume is not occupied by air. The collapsed condition may be enabled bya configuration of rolling, folds, pleats, contracted state of thematerial of which the receptacle is formed, etc. In other examples thereceptacle may be releasably held in a collapsed condition againstsurrounding portions of the diaper by a releasable mechanism such as apatch of releasable adhesive, a hook-and-loop system, a releasable tape,etc. When a volume of air is not initially present within the receptaclethat must be to be displaced to receive stool by pressure from adischarge thereof, the receptacle's receipt and acceptance of adischarge may be eased.

In some examples, the edges of a suitable bag structure about its openend may be sealingly affixed by adhesive or other suitable mechanismabout the perimeter of port 61, to the wearer-facing surface and/or tothe outward-facing surface of a liquid impermeable rear topsheet 16 r.Similarly, the edges of backsheet material about the port 61 may bedirectly or indirectly sealingly affixed to the outside surfaces of thereceptacle 61. To facilitate sealing about port 60, receptacle 61 mayinclude a sealing flange 62, which may be used to sealingly affixreceptacle 61 to the diaper. In the non-limiting examples shown, sealingflange 62 is sealingly affixed to the rear topsheet 15 r of the diaperabout port 60, however, other configurations are possible.

The receptacle 61 may be formed of a material containing or includingsubstantially no substances that will dissolve or otherwise intermixwith fecal matter, thereby reducing the potential for contamination ofthe sample. In some examples, the receptacle 61 may be formed of apolyolefin film, for example, polyethylene.

In some examples, the receptacle 61 may be deemed a continuation and/orextension of a liquid impermeable topsheet 16 r (such as suggested inFIGS. 4C and 6B). In some examples, the receptacle 61 may be deemed acontinuation and/or extension of a liquid impermeable backsheet 14 (suchas suggested in FIG. 4D), where the rear topsheet 16 r and the backsheet14 are essentially the same sheet/web component. In some examples asingle, unitary sheet or section of polymer film may be formed toconstitute the liquid impermeable rear topsheet 16 r and the receptacle61 as a continuous structure, wherein the rear topsheet 16 r andreceptacle 61 are integral.

The volume capacity of the receptacle is reflected by the liquid holdingcapacity of the portion of the receptacle, disposed below a horizontalx-y plane occupied by the topsheet stretched out horizontally againstcontraction induced by elastic members included in the diaper, to thefullest non-deformed dimensions of the non-elastic materials of thediaper, with the liquid at ambient pressure. For a receptacle positionedto receive stool discharge (i.e., with its center to the rear of alateral axis equally dividing the length of the diaper), it may bedesired that the receptacle have a liquid holding capacity of leastabout 5 ml, more preferably at least 10 ml, 25 ml or even 50 ml.

Referring to FIGS. 4E and 19A-E, the diaper also may be provided with astool gate 63 that will admit discharged stool into the receptacle 61and help retain the stool within the receptacle following discharge. Insome examples gate 63 may be formed of or include a sheet of polymerfilm or other suitable sheet material, and be disposed over and/oracross pass-through port 60 or otherwise over, across and/or in front ofthe wearer-facing end of receptacle 61. It may be desired that thematerial(s) used to form gate 63 be hydrophobic, or be treated to behydrophobic, so that discharged stool is less likely to adhere to it andwill more easily pass along the surfaces thereof. The sheet of film orother sheet material may have a gate entry 64 therethrough, which willallow stool to pass therethrough into receptacle 61. In some examplesgate entry 64 may be a slit, aperture or orifice through the sheet offilm or other sheet material. In examples illustrated in FIGS. 19B, 19Cand 19E gate entry 64 may include a curved slit through the sheetmaterial, or a configuration of line segments of slits through the sheetmaterial, that are configured to form flexible flaps 65 and/or otherwiseallow the sheet material thereabout to flex so as to create anadjustably-sized opening as a result of contact with and pressurethereagainst by a stool discharge. If the selected sheet material issubstantially elastic/resilient, the flexible flaps will substantiallyreturn to their original positions, reclosing gate entry 64 after stoolpasses therethrough. A stool gate 63 may be included to help isolatedischarged stool from contact with the wearer's skin, and help reducechances of contamination by urine, following discharge.

When the receptacle 61 is a bag structure, e.g., formed of a polymericfilm, upon a discharge of stool thereinto by an infant-patient, thecaregiver may collect the sample by separating the bag from the diaperby, e.g., cutting it away, e.g., with a pair of scissors. This enablesthe caregiver to remove the sample without immediately removing thediaper from the infant, facilitating neater sample collection. In otherexamples, the receptacle may be provided with features that make itdetachable about a perimeter proximate the perimeter of the pass-throughport 60. In one particular example, the receptacle may be provided witha line or path of perforations or scoring (not shown) about itsperimeter proximate the perimeter of the port 60. To prevent leakage,the perforations or scoring may be covered with a removable adhesivestrip (e.g. adhesive tape) (not shown) covering the perforations orscoring. Following a discharge of stool the caregiver may remove thestrip/tape, and tear the receptacle bag away from the diaper, along theline or path of perforations or scoring, and thereby collect the sample.In other examples, an adhesive used to sealingly affix the receptacle tothe portions of the diaper surrounding the port 60 may be a releasableadhesive, such that it will release its grip on the material of thereceptacle with relatively modest application of tugging, pulling orpeeling force exerted by the caregiver. In other examples, thereceptacle may be affixed to the diaper by frangible mechanical and/orthermal bonds which may be relatively easily broken and separated by thecaregiver via modest application of force.

In some examples, the receptacle may be provided with its own samplerelease port (not shown), valve or opening therein, at a locationremoved from that of pass-through port 60. The diaper may be initiallyprovided with a removable covering (not shown) or sticker over a samplerelease port or opening in the receptacle bag. Upon a discharge ofstool, the caregiver may remove the covering and to expel the contentsof the receptacle through the release port or opening, into a samplecontainer. In another example, the bag may be held sealingly closed at adistal end by an openable mechanism (not shown) such as, or havingcooperating features structurally similar to, any of a variety ofZIPLOC—(trademark of S.C. Johnson & Son, Inc., Racine, Wis.) type bagclosure devices. Following a discharge of stool into the receptacle, thedevice may be opened to empty a stool sample contained in thereceptacle, into a sample container.

It may also be desired that the material of which receptacle 61 isformed be substantially translucent such that a caregiver viewing it mayreadily visually detect whether the receptacle contains stool. Thus, itmay be desired that the material of which the receptacle is formed havean opacity no greater than 50 percent, more preferably no greater than45 percent, even more preferably no greater than 40 percent, and stillmore preferably no greater than 35 percent, as measured by the opacitytest method described below.

It will be appreciated that, where a pass-through port 60 of anysubstantial size is included, the plan surface area within the perimeterof the port reduces the plan surface area of the space between thetopsheet and backsheet that is available to be occupied by an liquidcontrol structure 15, acquisition layer 34, absorbent layer 35, urinecapture layer 34 a, or combination thereof. Referring to FIGS. 3B and4C, where a relatively larger urine storage capacity is required tominimize the chances that a stool sample will be contaminated bydischarged urine, it may be desired that the diaper include both a frontliquid control structure 15 f and a rear liquid structure 15 r, toprovide the desired urine storage capacity. Where discharged urine isprevented from traveling to the rear of the diaper over thewearer-facing side of the topsheet by, e.g., a transverse perinealbarrier 23, it may be desired that side passageways 15 c are included toprovide channels to enable fluid transport around port 60, between frontand rear absorbent structures 15 f, 15 r (see FIGS. 3B and 6B). Sidepassageways 15 c are portions of the enveloped space between thetopsheet and backsheet, laterally outboard of the side edges of the port60. Side passageways 15 c may be open channels or voids, substantiallyfree of any liquid control and/or absorbent materials, or may beoccupied by urine capture layer material, acquisition layer material orabsorbent layer material, or any combination thereof deemed suitable toprovide for controlled fluid transport between regions forward of port60 and rearward of port 60, within the envelope formed by the topsheetand backsheet. Thus, passageways 15 c may allow urine to travel from thefront of the diaper to the rear of the diaper, and be absorbed in rearliquid control structure 15 r in the event the front liquid controlstructure has insufficient capacity. In some examples port 60 may simplybe cut or punched through a liquid control structure, urine capturelayer or absorbent core structure, leaving front, rear and side portionsthereof intact and available to provide liquid transport and/orabsorption functions, where the side portions occupy side passageways 15c.

In some examples it may be desirable to include a pass-through port andreceptacle structure, as described above, toward the front of thediaper, i.e., forward of a lateral axis equally dividing the length ofthe diaper, for purposes of providing a volume of space tonon-absorbably receive and retain urine discharged by the infantpatient. Such a forward structure (not shown) may be positionedappropriately proximate the intended wearer's urethra/urine dischargelocation. Such a forward structure may have any of the features or anycombination of the features described above, and may be provided incombination with, or as an alternative to, a rear port and receptaclestructure, where an isolated volume and receptacle for non-absorbablereceipt and retention of discharged urine may be desired.

Transverse Perineal Barrier

As reflected in FIGS. 1, 2A and 4A-4D, diaper 10 may include atransverse perineal barrier 23. Transverse perineal barrier 23 may bedisposed in the perineal portion 13 of the diaper, suitably located toextend transversely across the diaper, between the anus and genitals ofthe wearer when the diaper is worn. A single diaper design may bemanufactured with a transverse perineal barrier in a location suitablefor both male and female wearers. Alternatively, a selection of at leasttwo differing designs may be manufactured (and simultaneously offeredfor purchase, e.g., in an array), one for male wearers and one forfemale wearers. The two designs may differ in, at least, the location ofthe transverse perineal barrier, with one design having the perinealbarrier in a location more closely suited to male wearer anatomy, andthe other design having the perineal barrier in a location more closelysuited to female wearer anatomy.

Transverse perineal barrier 23 may have a proximal portion 24 and a freedistal edge 25. Free distal edge 25 of perineal barrier 23 may bridgerespective free distal edges 20 of left and right standing longitudinalcuffs 18 or outer longitudinal cuffs 18 a.

Transverse perineal barrier 23 may be formed of an effectively liquidimpermeable material. In one example, it may be formed of a polymerfilm. In another example, it may be formed of an effectively liquidimpermeable fibrous nonwoven web material, or a laminate of a polymerfilm and a fibrous nonwoven web material. In one example, perinealbarrier 23 may be formed of the same type material as longitudinal cuffs18.

Transverse perineal barrier 23 may be transversely affixed along theproximal portion 24 to an underlying component of the diaper structureby mechanical or thermal bonding, by adhesive or other means, or acombination thereof; however, use of adhesive to bond or supplementallybond proximal portion 24 to the structure may serve to provide a liquidseal at the junction between the barrier 23 and the underlying diaperstructure. In one example, proximal portion 24 of the barrier 23 isbonded to the rear topsheet 16 r with a continuous application ofadhesive therebetween, to provide a liquid seal at the junction. Theadhesive may be a hot-melt type adhesive conventionally used in themanufacture of disposable diapers.

In some examples it may be desired that rear topsheet 16 r and perinealbarrier 23 are continuously integrally joined where they meet, therebypreventing escape of liquid at the junction therebetween. In one examplesuggested in FIG. 4A, an effectively liquid impervious sheet or webmaterial (such as a polymer film) forming rear topsheet 16 r in whole orin part may contiguously form a portion or layer of perineal barrier 23.It may also be desired that side edges 26 of perineal barrier 23 arecontinuously integrally joined to the material forming longitudinalcuffs 18, thereby preventing escape of liquid at a junctiontherebetween.

Transverse perineal barrier 23 may be manufactured to have asubstantially straight free distal edge 25 and may also include one ormore perineal barrier elastic members 27. In a manner similar toinclusion of longitudinal cuff elastic members 19, during manufacturing,perineal barrier elastic members 27 may be incorporated and affixed intothe barrier 23 structure in a pre-strained condition. Upon completion ofmanufacturing, release from the manufacturing line, and relaxation ofthe diaper structure, the elastic members 27 contract toward theirunstrained lengths, causing the free distal edge 25 of barrier 23 topull transversely against the respective free distal edges 20 of thelongitudinal cuffs. When the longitudinal cuffs 18 “stand” as describedabove, this causes the perineal barrier 23 also to “stand”. This featurecauses the free distal edge 25 of the perineal barrier 23 to draw towardthe wearer's skin across the perineum, when the diaper is worn, therebyperforming a gasketing function that serves to prevent passage of liquidexudates between the cuffs 18 from the rear portion of the diaper 11 tothe front portion of the diaper 12, and vice versa. Thus, urine exudatein the front of the diaper may be prevented from contaminating stoolexudate contained in the rear portion of the diaper, and liquidconstituent of stool exudate may be prevented from moving to the frontportion 12 of the diaper where it could pass through a liquid permeablefront topsheet 16 f into the liquid control structure.

As suggested in FIGS. 4A and 4B, the transverse perineal barrier 23 maybe configured such that a marginal portion proximate to distal edge 25tends to bend over, which will cause it lay in a flat configurationagainst the wearer's skin when the diaper is worn. This may improvecomfort of the diaper and reduce any tendency of the transverse barrierto chafe or mark the wearer's skin. In one example, elastic members 27may be one or more flattened strips of elastomeric material (rather thanround strands), which may further enhance the tendency of the marginalportion to bend and lay over flat against the wearer's skin. In oneexample, the marginal portion at left and right sides thereof may beattached to longitudinal cuffs along a direction that is notperpendicular to, or even substantially parallel to, to the free edges20 of the cuffs, serving to urge the marginal portion into a bent-overconfiguration when the diaper is worn.

For purposes of maximizing a gasketing function pulling the cuffs andperineal barrier toward the wearer's skin, it may be desired that freedistal edge 25 of transverse perineal barrier 23 is affixed to eachlongitudinal cuff 18 at a location within 5 mm or less, more preferablywithin 2 mm or less, of each free distal edge 20 of each longitudinalcuff 18. For the same purpose, and alternatively or in combinationtherewith, it may be desired that the perineal barrier 23 is configuredsuch that at least one and preferably all of perineal barrier elasticmembers 27 are disposed with their ends or some portion proximate theirends no more than 5 mm or less, more preferably no more than 2 mm orless, of a longitudinal cuff elastic member 19. This helps create aneffectively continuously elasticized, tailored gasketing structure thatmore closely fits the wearer's body in front and to the sides of theanus.

FIGS. 4A-4D depict transverse perineal barrier 23 extending from itsattached proximal portion 24 at an angle of extension therefrom downwardin the figures, i.e., toward the front portion/front waist region 12 ofthe diaper. In some examples such an angle may be preferred to enhancecontainment of urine and/or isolation of urine from stool, for example,where preservation of the integrity of a stool sample is the primaryobjective. In other examples, the transverse perineal barrier may beangled toward the rear of the diaper, such that it extends from itsattached proximal portion toward the rear portion/rear waist region 11of the diaper. This may enhance containment of liquid stool and/orisolation of stool from urine, for example, where preservation of theintegrity of a urine sample is the primary objective.

With the diaper viewed in plan view in an extended configuration, anangle of extension of perineal barrier 23 is manifest by a longitudinaloffset between the location at which the proximal portion 24 is attachedto the underlying structure, and the location at which the free distaledge 25 meets the longitudinal cuffs 18. The angle of extension may beeffected, as thereby suggested, by respectively attaching the proximalportion 24 of perineal barrier 23 to the underlying structure (such asthe topsheet), and the distal edge 25 to the longitudinal cuffs 18, atlongitudinally differing locations on the diaper.

In addition to, or in combination with, the features described above,the transverse perineal barrier 23 may generally be imparted withfeatures, configurations and/or structures associated with cuffconnectors, transverse separators and/or transverse separator sheetsdescribed in US2016/0038350; US2015/045761; US2015/045760;US2015/045759; US2015/0257946; US2015/0223996; US2015/0209195;US2014/0221955; U.S. Pat. No. 9,050,219; U.S. Pat. No. 9,050,218; U.S.Pat. No. 6,786,895; U.S. Pat. No. 6,010,490; EP0988013A1; andEP0929277B1.

Transverse Rear Cuff

As reflected in FIGS. 1, 2A and 4, diaper 10 may include a transverserear cuff 28 c. A transverse rear cuff 28 c may help the rear portion 11of the diaper more effectively contain highly liquid stool, particularlywhen discharged in rapid or forceful bowel movements.

Transverse rear cuff 28 c may be disposed in the rear portion 11 of thediaper. Transverse rear cuff 28 c may have a proximal portion 29 c and afree distal edge 30 c. Free distal edge 30 c of rear cuff 28 c maybridge the respective free distal edges 20 of the left and rightstanding longitudinal cuffs 18.

Transverse rear cuff 28 c may be formed of an effectively liquidimpermeable material. In one example, it may be formed of a polymerfilm. In another example, it may be formed of an effectively liquidimpermeable fibrous nonwoven web material, or a laminate of a polymerfilm and a fibrous nonwoven web material. In one example, rear cuff 28 cmay be formed of the same type material as longitudinal cuffs 18.

Transverse rear cuff 28 c may be transversely affixed along the proximalportion 24 to the diaper structure by mechanical or thermal bonding, byadhesive or other means, or a combination thereof, however, use ofadhesive to bond or supplementally bond proximal portion 24 to thestructure may serve to provide a liquid seal at the junction between thebarrier 23 and the diaper structure. In one example, proximal portion 29c of the rear cuff 28 c is bonded to the rear topsheet 16 r with acontinuous application of adhesive therebetween, to provide a liquidseal at the junction. The adhesive may be a hot-melt type adhesiveconventionally used in the manufacture of disposable diapers.

In some examples it may be desired that rear topsheet 16 r and rear cuff28 c are continuously integrally joined where they meet, therebypreventing escape of liquid at the junction therebetween. In oneexample, an effectively liquid impervious sheet or web material (such asa polymer film) forming rear topsheet 16 r in whole or in part maycontiguously form a portion or layer of rear cuff 28 c. It may also bedesired that side edges 33 c of rear cuff 28 c are continuouslyintegrally joined to the material forming longitudinal cuffs 18, therebypreventing escape of liquid at a junction therebetween.

Transverse rear cuff 28 c may be manufactured to have a substantiallystraight free distal edge 30 c and may also include one or more rearcuff elastic members 31 c. In a manner similar to inclusion oflongitudinal cuff elastic members 19, during manufacturing, rear cuffelastic members 31 c may be incorporated and affixed into the rear cuff28 c structure in a pre-strained condition. Upon completion ofmanufacturing, release from the manufacturing line, and relaxation ofthe diaper structure, the elastic members 31 c contract toward theirunstrained lengths, causing the free distal edge 30 c of rear cuff 28 cto pull transversely against the respective free distal edges 20 of thelongitudinal cuffs. When the longitudinal cuffs 18 “stand” as describedabove, this causes the rear cuff 28 c also to “stand”. This featurecauses the free distal edge 30 c of the rear cuff 28 c to draw towardthe wearer's skin above the wearer's gluteal cleft, when the diaper isworn, thereby performing a gasketing function that serves to preventpassage of liquid exudates between the cuffs 18 and out of the rearportion 11 of the diaper 10. Thus, liquid constituents of stool exudatemay be prevented from escaping the diaper.

For purposes of maximizing a gasketing function pulling the distal edges20 of longitudinal cuffs 18 and distal edge 30 c of rear cuff 28 ctoward the wearer's skin, it may be desired that free distal edge 30 cof transverse rear cuff 28 c is affixed to each longitudinal cuff 18 ata location within 5 mm or less, more preferably within 2 mm or less, ofeach free distal edge 20 of each longitudinal cuff 18. For the samepurpose, and alternatively or in combination therewith, it may bedesired that the rear cuff 28 c is configured such that at least one andpreferably all of rear cuff elastic members 31 c are disposed with theirends or some portion proximate their ends no more than 5 mm or less,more preferably no more than 2 mm or less, of a longitudinal cuffelastic member 19. This helps create an elasticized, tailored gasketingstructure that more closely fits the wearer's body to the rear of theanus. In combination with the configuration of elastic members describedabove, a gasketing structure substantially entirely circumscribing thewearer's anus is thereby created.

Any one, combination of, or all, of the elastic members in thelongitudinal cuffs, transverse perineal barrier and transverse rear cuffdiscussed above may be may be formed of strands (round-cross section) orstrips (rectangular cross section) of elastomeric material. Suitableexamples of elastomeric material include natural rubber strands asavailable from Easthampton Rubber Company of Stewart, Va., under thetrademark L-1900 Rubber Compound; natural rubber elastic tape sold underthe trademark Fulflex 9411 by Fulflex Company of Middletown, R.I.;polyurethane; and synthetic elastomers (e.g., LYCRA strands from InvistaCorp., Wichita, Kans.).

Liquid Control Structure

As noted above, a liquid permeable front topsheet 16 f, such as anapertured nonwoven front topsheet 16 f, which may be adapted to behydrophilic, may be preferred.

Underlying the front topsheet 16 f, liquid control structure 15 ispreferably configured to provide for rapid acquisition, distribution toabsorbent components, and absorption of urine, quickly after adischarge. Rapid absorption of urine reduces the chance that urine mayescape the front portion of the diaper to the rear portion of the diaperabove the rear topsheet 16 r, and contaminate stool that may be presentin, or later be discharged in, the rear portion.

Accordingly, it may be desired that the liquid control structure includean acquisition layer 34 beneath the front topsheet 16 f and above anabsorbent layer 35. Layer 34 may have the form of, e.g., a layer, mat orother body formed of or including, e.g., comminuted cellulose fibers, orother hydrophilic natural, semi-synthetic or synthetic fibers or othermaterial that may be used to form a mat, layer or other body. Othersuitable materials for forming an acquisition layer 34 are described in,for example, U.S. Pat. App. Pub. No. 2004/0158213.

In one example, the acquisition layer 34 may include a nonwoven matformed of fibers, which may be manufactured or adapted to behydrophilic. In one example, acquisition layer 34 may include chemicallycross-linked cellulosic fibers, which may or may not form part of anonwoven material. In another example, acquisition layer 34 may includea nonwoven without the cross-linked cellulosic fibers. In anotherexample, the acquisition layer may include chemically cross-linkedcellulosic fibers mixed with other fibers such as natural or syntheticpolymeric fibers. In some examples, such other natural or syntheticpolymeric fibers may include high surface area fibers, thermoplasticbinding fibers, polyethylene fibers, polypropylene fibers, PET fibers,rayon fibers, lyocell fibers, eucalyptus fibers and mixtures thereof.Suitable non-woven materials for the acquisition layer may include, butare not limited to, SMS material, including a spunbonded, a melt-blownand a further spunbonded layer. In certain examples, permanentlyhydrophilic nonwovens, and in particular, nonwovens with durablyhydrophilic coatings are desirable. Another suitable example includes anSMMS-structure. In such examples, the nonwovens are highly porous.

The absorbent layer 35 may be formed of any absorbent material that isgenerally compressible, conformable, nonirritating to the wearer's skinwhen positioned as shown and described herein, and capable of absorbingand retaining liquids such as urine. Absorbent layer 35 may comprise awide variety of liquid-absorbent materials commonly used in disposablediapers and other absorbent articles such as comminuted wood pulp, whichis generally referred to as air felt or fluff. Examples of othersuitable absorbent materials include creped cellulose wadding; meltblown polymers, including co-form; chemically stiffened, modified orcross-linked cellulosic fibers; tissue, including tissue wraps andtissue laminates, absorbent open-celled foams (such as, for example,described in U.S. Pat. Pub. No. 2015/0313770), absorbent sponges,superabsorbent polymers (such as superabsorbent fibers), absorbentgelling materials, hydrogel-forming particles, or any other knownabsorbent material or combination of materials. Examples of somecombinations of suitable absorbent materials are cellulosic fiber fluffblended or interlaced with absorbent polymer particles, absorbentgelling materials and/or superabsorbent polymers, and absorbent gellingmaterials and super absorbent fibers etc. The storage layer may furthercomprise minor amounts (typically less than 10%) of non-liquid absorbentmaterials, such as adhesives, waxes, oils and the like. In someexamples, the absorbent layer 35 may comprise materials and beconfigured as described in U.S. Patent Applications, Pub. Nos.US2014/0163511; US2014/0163503; US2014/0163501; US2014/0163500;US2012/0316526; US2012/0316528; US2014/0163501; and US2014/0371701.

The absorbent layer 35 may include absorbent polymer particles alone orin combination with other materials, such as cellulose fiber. Theabsorbent polymer particles may be immobilized on a substrate layer by,for example, a thermoplastic adhesive material. Absorbent polymerparticles suitable for use in the absorbent layer may include anyabsorbent polymer particles known from superabsorbent literature, forexample such as described in Modern Superabsorbent Polymer Technology,F. L. Buchholz, A. T. Graham, Wiley 1998. The absorbent polymerparticles may be spherical, spherical-like, ellipsoid, or irregularlyshaped, such as ovoid-shaped particles of the kind that may be obtainedfrom inverse phase suspension polymerizations. The particles may,optionally, be agglomerated at least to some extent to form largerirregular agglomerations of particles. The absorbent polymer particlesmay be selected from among polyacrylates and polyacrylate basedmaterials that are internally and/or surface cross-linked, such as forexample partially neutralized cross-linked polyacrylates or acidpolyacrylate. Examples of absorbent polymer particles suitable in thepresent disclosure are described for instance in U.S. Pat. No.5,714,156, and PCT Patent Applications Nos. WO 07/047598, WO 07/046052,WO2009/155265 and WO2009/155264. In alternative examples, the absorbentlayer may be substantially cellulose-free. (Herein, “substantiallycellulose free” means that the absorbent layer has less than about 10percent by weight cellulose fiber.) Airfelt and other cellulose fiberhave been used as absorbent fillers in absorbent cores of disposablediapers. Such fiber possesses absorbent properties and imparts someabsorption capacity to an absorbent layer, but also may be included toprovide a structural matrix to hold dispersed particles of absorbentpolymer particles. While inclusion of such particles enhances absorptioncapacity, keeping such particles suitably dispersed may be important toprevent the particles from “gel-blocking” in use as they swell withabsorbed liquid and block the passageways therebetween which allowliquid to move through deposits thereof, compromising absorptioncapacity. The inclusion of airfelt or other cellulose fiber as a matrixfor absorbent polymer particles can serve to reduce or preventgel-blocking. However, it also imparts bulk to an absorbent layer, evenbefore absorption of any liquids. To reduce the overall size and/orthickness of the absorbent layer, it may be desired to construct aliquid control structure using the lowest volumes of materials possiblewithin performance constraints. Toward this end, examples of suitablematerials and constructions for a suitable absorbent structure aredescribed in, but are not limited to, U.S. applications Ser. Nos.12/141,122; 12/141,124; 12/141,126; 12/141,128; 12/141,130; 12/141,132;12/141,134; 12/141,141; 12/141,143; and 12/141,146; and WO2008/155699.Generally, these applications describe absorbent layer constructionsthat minimize or eliminate the need for and inclusion of airfelt orother forms of cellulose fiber in combination with particles ofabsorbent polymer particles. Suitable methods for forming deposits ofabsorbent polymer particles are additionally disclosed in, for example,EP1621167A2, EP1913914A2 and EP2238953A2. The absorbent polymerparticles may be immobilized on the substrate layer. Immobilization maybe achieved by applying a thermoplastic adhesive material, which holdsand immobilizes the absorbent polymer particles, and cellulose whenpresent, on the substrate layer. Some thermoplastic adhesive materialmay also penetrate into the layer of absorbent polymer particles andinto the substrate layer to provide further immobilization andaffixation. The thermoplastic adhesive material may not only help inimmobilizing the absorbent polymer particles on the substrate layer butalso may help in maintaining the integrity of any liquid channelsthrough the structure that may be included. The thermoplastic adhesivematerial may help prevent migration of any substantial quantity ofabsorbent polymer particles into the channels. Thermoplastic adhesivematerials suitable for use in the present disclosure includes hot meltadhesives including at least a thermoplastic polymer in combination witha plasticizer and other thermoplastic diluents such as tackifying resinsand additives such as antioxidants. Example suitable hot melt adhesivematerials are described in EP1447067A2.

Particularly in diapers for babies older than 12 months, toddlers andyoung children, it may be important that liquid control structure 15have absorbent storage capacity sufficient to absorb and effectivelyretain a substantial quantity of urine. Accordingly, as suggested inFIG. 4A, it may be desired that absorbent layer 35 be of a size thatcauses it to have a substantial volume absorbent capacity. In oneexample, the absorbent layer 35 may extend over a majority of the plansurface area of the diaper beneath the front topsheet 16 f alone, fromthe attached proximal portion 24 of transverse perineal barrier 23forward. In another example, the absorbent layer 35 may extend amajority of the length of the diaper 10, and be present not only in thefront portion 12 but also in the perineal portion 13 and rear portion11, and thus be present between the backsheet and the front topsheet,and between the backsheet and the rear topsheet. For purposes ofefficient, even and rapid distribution of urine across the entirety ofthe absorbent layer 35, it may be desired that acquisition layer 34cover a majority of the plan surface area of the absorbent layer 35.

In some circumstances, it may be desired to use the diaper, additionallyor alternatively, as a urine sample collection device. Generally in suchcircumstances, it may be desired that the diaper be adapted to receiveand hold urine discharged by the wearer without substantially retainablyabsorbing the urine, and without altering the composition of the urinesolution, e.g., by contaminating it with soluble materials included asor on components of the diaper in areas in which urine will be receivedand collected. For example, it may be desired the that the liquidcontrol structure be adapted to provide space for urine to be receivedand held, but not contain substantial quantities of materials that tendto retainably absorb and/or capture urine constituents. For purposes ofmaintaining open space between the liquid impermeable backsheet and thewearer-facing layer to receive and hold urine, but to prevent it fromflowing freely throughout the space, it may be desired that the liquidcontrol structure include a substantially non-absorbent material, forexample, a batt of material formed of an accumulation of substantiallynon-absorbent polymer fibers. To reduce or prevent substantialabsorption and/or alteration of the composition of the urine, it mayalso be desired that the liquid control structure not contain asubstantial quantity of water-absorbent material of any of the typestypically used in disposable diapers, disposable absorbent pants andother absorbent personal hygiene products, i.e., cellulose/cellulosicfibers; absorbent sponge; absorbent foam; superabsorbent polymer;absorbent gelling material; hydrogel-forming particles; and/or absorbentpolymer particles (collectively, “absorbent material”). Thus, it may bedesired that at least 50 percent of the volume of the liquid controlstructure, as defined by its plan surface area, contain no more than 50percent, more preferably no more than 35 percent, even more preferablyno more than 20 percent, or 10 percent, or 5 percent and still morepreferably no more than an insubstantial quantity or even about 0percent, by weight absorbent material. It may be even further preferredthat at least 65 percent, or 80 percent, 90 percent, 95 percent or evensubstantially all of the volume of the liquid control structure, asdefined by its plan surface area, contain no more than 50 percent, morepreferably no more than 35 percent, even more preferably no more than 20percent, or 10 percent, or 5 percent and still more preferably no morethan an insubstantial quantity or even about 0 percent, by weightabsorbent material.

Non-Reliance on Adhesive-to-Skin Contact

As noted, premature and very young infants may have very sensitive anddelicate skin. Adhering devices via an adhesive composition may bepainfully irritating or even damaging to such an infant's skin. For thisreason, it may be deemed desirable in such circumstances that the diaper10 have no features adapted to be adhered to the wearer's skin andrequired for use of the diaper.

Packaging Configuration and Information

It may be desirable to provide a separate package for each individualdiaper. A diaper as described herein may be deemed a product for medicaluse or treatment. Thus, individual packaging of each diaper may bedesirable for purposes of actually or perceivably maintaining a level ofsterility, cleanliness, purity and structural integrity of eachindividual diaper until use, in a manner similar to the manner in which,e.g., individual bandages are packaged. A supply of individuallypackaged diapers may be packaged as a group in a larger outer package.

In the event that a composition, for example, a water-solublesurfactant, is included in or on materials of the diaper within thespace that stool will contact, it may be desirable to includeinformation with the individual or group packaging associated with thediaper, or even on the diaper itself, effective to notify health careand/or analytical personnel of the inclusion of the composition in thediaper. Other information useful for enabling the caregiver to identify,quantify or isolate components or attributes of the stool samplerecovered from the diaper may also be included with the packaging. Inone additional non-limiting example, the weight of the individual diapermay be recorded on the packaging or on material(s) included with thepackaging. This will enable the caregiver to calculate the quantity byweight of stool discharged by the patient, from, e.g., the weight of thediaper prior to use, and the measured weight of the diaper after itsremoval from the wearer following a discharge of exudate, prior toremoval of the sample from the diaper. In one example, such informationmay be printed on the diaper itself, such as on an outward-facingsurface of the backsheet or a visible layer thereof.

It may also be desirable to include information and/or indiciaassociated with the diaper, individual packaging (if included) or outerpackaging, identifying the diaper as a special-use diaper, anddistinguishing it from ordinary diapers. This will serve to notifyhealthcare professionals or other caregivers of the special design ofthe diaper, and help avoid confusion, inappropriate use of thespecial-use diaper for ordinary purposes, and intermixing of supplies ofthe special-use diapers with supplies of ordinary diapers.

Non-Invasive Method for Collecting Stool Sample from an Infant

Utilizing a suitable example of a diaper 10 as described herein, ahealth care professional or caregiver may obtain a stool sample from aninfant by the following steps:

-   -   Applying the diaper to a patient-wearer in the same manner as a        conventional disposable diaper;    -   Detecting a discharge of stool by the patient-wearer; this may        include observing the wearer for facial, audible or        body-language signals that he or she has eliminated; feeling the        diaper to detect the presence of stool; or observing a change in        appearance of the diaper resulting from the presence of stool;    -   Removing the diaper from the patient-wearer, or alternatively,        removing a portion of a receptacle from the diaper;    -   Locating the diaper or receptacle proximate to a sample        container; and    -   Emptying the stool from the diaper or receptacle into the sample        container.

The above-described method, employing an example of a diaper asdescribed herein, may provide improved facilitation in obtaining a stoolsample from an infant, without the need for invasive devices ortechniques or the application of an adhesive to the infant's skin.

Examples of Features for Urine Sample Collection

Any of the features of a diaper useful for collection of a stool sample,described above, may be included with a diaper also useful forcollection of a urine sample. Features useful for collection of a urinesample are set forth in the following description.

FIGS. 9-17B depict various features that may be embodied individually orin any combination in a diaper 10. Diaper 10 may have a rear waistregion 11, front waist region 12 and crotch region 13 between the frontwaist region and rear waist region. For reference, the lateral width ofdiaper 10 may be equally divided by an imaginary longitudinal axis 12-12(FIG. 10A).

Topsheet

Diaper 10 may include a liquid control structure 15 adapted to receiveand control, and in some circumstances absorb and retain liquid exudates(e.g., urine). As may be seen in FIGS. 12-14, diaper 10 may include atopsheet overlying the liquid control structure 15 such that liquidcontrol structure 15 is disposed in the diaper between the backsheet 14and the topsheet 16 in the front waist region 12.

Topsheet 16 may be formed of a liquid permeable material, for example, anonwoven material such as described in U.S. Pat. No. 8,968,614. Forpurposes of ensuring passage of urine through the topsheet 16 to thematerials of the liquid control structure 15, thereby minimizing chancesof loss or contamination of a urine sample, it may be desired that thetopsheet 16 be formed of an apertured nonwoven material formed offibers. The fiber constituents may be selected or manufactured to beinherently hydrophilic, or may be treated, e.g., with an application ofa suitable surfactant, to impart hydrophilic surface properties.Suitable examples of apertured topsheets are described in U.S. Pat. Nos.7,033,340; 6,680,422; 6,498,284; 6,414,215; 5,516,572; and 5,342,338;and in pending U.S. application Ser. No. 14/270,468. In one example,synthetic polymer fiber constituents of a topsheet, such as fibers spunfrom polypropylene and/or polyethylene resin (ordinarily hydrophobicmaterials) may be treated to impart them with hydrophilic surfaces usingthe materials and method described in, for example, U.S. App. Pub. No.2011/0015602. Following such treatment, the hydrophilizing materials arecross-linked and/or chemically grafted to the fiber constituents, suchthat they do not wash off (i.e., dissolve) in aqueous liquid (e.g.,urine).

In another example, topsheet 16 may be formed of an apertured film. Useof an apertured film may be preferred, for example, in diapers for usewith premature or very young and/or relatively small infants. Suchdiapers are typically assigned a size designation of 2 or lower, 1 orlower, or even 0 or lower. Such infants usually have relatively smallbladder capacity and may discharge only small quantities of urine (e.g.,less than about 50 mL) in a single discharge. The benefit of anapertured film topsheet is that it may be less likely and/or capable ofretainably absorbing a substantial quantity of urine, than a topsheetformed of a fibrous nonwoven material. In a more specific example,topsheet 16 may be formed of an apertured formed film, or in an evenmore specific example, a vacuum formed apertured film. Features ofsuitable examples of apertured films are commonly found in topsheets incurrently marketed feminine hygiene pads, and are also disclosed in, forexample, U.S. Pat. Nos. 8,679,391; 6,471,716; 6,989,187 and 4,629,643;and U.S. Pat. App. Pub. No. 2015/0273793.

As will be further appreciated from the description below, in someexamples of the diaper herein, and in contrast to conventionaldisposable diapers, the patient-wearer's urine might not be absorbed ina structure beneath the topsheet to a substantial degree. Rather,following discharge, the urine may flow through the topsheet and be heldsubstantially unabsorbed in the enveloped space between the topsheet andbacksheet, until the diaper is removed from the wearer and the urine isexpressed and/or poured out into a sample container. Therefore, it maybe desired that the topsheet be adapted to permit the urine to moverelatively freely after discharge, from the wearer-facing side of thetopsheet through to the outward-facing side of the topsheet and into theenvelope space, but to obstruct or inhibit urine flow back through thetopsheet from the envelope space toward the wearer.

In one example suitable for such purpose, an apertured film topsheet maybe used, particularly one having a pattern of apertures 36 that aredefined by funnel structures 37 as depicted in FIGS. 15 and 16. Forpurposes herein, a “funnel structure” is characterized as a structuredefining an aperture (passageway) through the topsheet that is larger onthe wearer-facing (liquid entry) side than on the outward-facing (liquidexit) side. Referring to FIG. 16, by way of non-limiting example, forapertures 36 that are circular in shape when the topsheet is viewed inplan view, the aperture/passageway on the wearer-facing side 38 of thetopsheet will have diameter DW, and the aperture/passageway on theoutward-facing side will have diameter DO. In the example depicted, thepassageway roughly defines a cone shape. For a circular/cone-shapedfunnel structure 37, DW will be greater than DO. Apertured filmtopsheets having such funnel structures can be manufactured by vacuumforming or otherwise as described in the above-cited references. It willbe appreciated, that apertures and funnel structures need notnecessarily be circular/cone-shaped; see, e.g., the various shapes forfunnel structures depicted and described in U.S. Pat. No. 6,989,187.Without intending to be bound by theory, it is believed that the funnelstructures, being formed of relatively thin and pliable polymeric filmmaterials, tend to collapse toward their centers when fluid exertspressure against the outward-facing surface 39. It is believed that thiscollapsing behavior causes the apertures to partially or entirely close;thus, the funnel structures function like one-way check valves that tendto permit fluid to flow through from the wearer-facing side 38 to theenvelope space, and tend to obstruct or inhibit flow back through thetopsheet from the envelope space, from the outward-facing side 39 andtoward the wearer.

In some circumstances, it may be desired that a film topsheet not beincluded. Rather, a topsheet formed of nonwoven web, or even no topsheetoverlying the liquid control structure, may be desirable. Particularlywhen use with premature infants is contemplated, a film topsheet maypresent a risk of sticking to the skin, which may be undesirable in somecircumstances because a premature infant's skin may be very delicate.

Urine Capture Layer

As discussed above, topsheet 16, which may be adapted to allowdischarged urine to freely pass therethrough, may be desired.Additionally, it may be desired that the diaper include a urine capturelayer 34 a beneath the topsheet 16 and above the backsheet 14.

Urine capture layer 34 a may be included and may serve one or morefunctions: (1) to provide an open structure that occupies a volume, andthereby ensures the presence of space within the envelope structurebetween topsheet 16 and backsheet 14, available to receive urine whilethe diaper is being worn by an infant; (2) to absorb and dispersekinetic energy in a gush of urine during discharge by the wearer,thereby slowing and controlling flow thereof inside the diaper andreduce the chances of a leak; and (3) to provide a matrix structure thatholds urine and restricts rapid flow back and forth within the volumeoccupied by the layer, reducing the chances of a leak, prior to the timethe diaper is removed for urine sample retrieval.

Because a purpose of the diaper 10 as described herein may be toinitially receive and collect, but then release, urine to be sampledupon removal from the patient, it may be desired that urine capturelayer 34 a does not have substantially absorbent properties. This may beparticularly important for younger infant patients, who urinate in onlyrelatively small volumes at a time.

Accordingly, it may be desired that urine capture layer 34 a be formedof or include a batt or pad of accumulated synthetic fibers spun fromsuitable polymeric resin(s), or a single- or multilayer section offibrous nonwoven web material comprising fibers spun or otherwise formedof such resin(s). The resin(s) may be selected such that the fibersformed therefrom have hydrophobic surface properties, and thereby do nottend to attract or retainably hold aqueous liquid in the interstitialspaces within the fiber matrix, or otherwise, freely give up deposits ofaqueous liquid upon light compression (light squeezing, rolling orwringing) of the diaper. Suitable materials and additives for forming aurine capture layer 34 a are described in, for example, U.S. Pat. No.8,598,406 and US 2004/4158213. If desired, additives and/or treatmentsthat render the fibers hydrophilic may be omitted, to reduce theabsorbency of the layer 34 a. Examples of suitable synthetic,hydrophobic fibers which may be used to form all or a portion of a urinecapture layer include fibers formed of one or more polyolefins(polyethylene and polypropylene). Alternatively, to promote distributionof discharged urine within the volume occupied by the liquid controlstructure, thereby enhancing capacity, urine capture layer 34 a may beformed of or include a batt or pad (one or more layers thereof)including synthetic fibers spun or otherwise formed of materials thatyield fibers that have hydrophilic surface properties. In addition toenhancing capacity, by having some attraction for aqueous liquid,hydrophilic fibers may reduce uncontrolled movement of urine back andforth within the liquid control structure. Non-limiting examples ofsynthetic materials that may be used to form such fibers includepolyamides (e.g., nylon); polyesters (e.g., polyethylene terephthalate(PET)); polylactic acid (PLA); rayon; viscose and lyocell. In oneexample, urine capture layer 34 a may include a blend of bothhydrophilic synthetic fibers and hydrophobic fibers (such as fibers spunfrom polyolefins such as polypropylene and/or polyethylene). In anotherexample, a multi-layered structure including, e.g., a layer formedpredominately of synthetic hydrophobic fibers, and a layer formedpredominately of hydrophobic fibers, to balance performance with respectto effective distribution of urine through the liquid control layer, anda desired level of non-absorbency and/or average Liquid Release Ratiofor the diaper (described below).

Other naturally hydrophilic fiber components may be included in theurine capture layer following urination. Such components may includenatural fibers, including but not limited to cellulosic fibers such aswood pulp fibers (included treated wood fibers) and cotton fibers, flax,linen and hemp fibers, and animal fibers such as wool, silk, fur andhair fibers. In another alternative, it may be desired to treathydrophobic material(s) forming urine capture layer 34 a with asurfactant composition to render their surfaces hydrophilic. In oneexample, synthetic polymer fiber constituents of a urine capture layer34 a, such as fibers spun from polypropylene and/or polyethylene resin(ordinarily hydrophobic materials) may be treated to impart them withhydrophilic surfaces using the materials and method described in, forexample, U.S. App. Pub. No. 2011/0015602. Following such treatment, thehydrophilizing materials are cross-linked and/or chemically grafted tothe fiber constituents, such that they do not wash off (i.e., dissolve)in aqueous liquid (e.g., urine).

In another example, or in combination, synthetic polymer fiberconstituents of a urine capture layer 34 a, such as fibers spun frompolypropylene and/or polyethylene resin (ordinarily hydrophobicmaterials) may be treated to impart them with hydrophilic surfaces byapplication of one or more of the materials described in, for example,U.S. Pat. No. 8,178,748. The '748 patent identifies materials such asARLAMOL PS15E (a PPG-15 stearyl ether formulation currently availablefrom Croda International Plc, East Yorkshire, UK). Such a material mayprovide an advantage in that it imparts hydrophilicity to the surfacesof synthetic polymer fibers, while being insoluble in water and tendingto remain adhered to the fiber surfaces, and thus may not dissolve orbecome dispersed in the desired urine sample and thereby contaminate it.Other materials that may have similar properties and advantages mayinclude, but are not limited to, those comprising functionalities ofpolyethylene glycol (PEG), polypropylene glycol (PPG), and polybutyleneglycol (PBG) functional groups can be used to treat a portion of thenonwoven 24 to form the hydrophilic zone 37. Nonionic surfactants havinga functional group selected from the group consisting of polyethyleneglycol (PEG), polypropylene glycol (PPG), polybutylene glycol (PBG), andcombinations thereof can be used to treat a portion of the nonwoven 24to form the hydrophilic zone 37. The degree of polymerization of apolyether functional group in a non-ionic surfactant can be betweenabout 2 and about 100. Because examples of such materials may berelatively stable, oily liquids that do not evaporate at roomtemperature within time periods in circumstances contemplated herein, itmay be desired that they be applied to surfaces underlying a topsheet orother wearer-facing surface or layer, so as not to be susceptible tobeing rubbed off by contact with the wearer.

In conjunction with the inclusion of a soluble surfactant composition orother soluble additives, the diaper 10 can be provided with associatedpackaging, package insert or other media bearing information effectiveto notify health care and/or analytical personnel of the inclusion ofthe soluble surfactant composition in the diaper. Alternatively, suchinformation may be printed on the diaper itself, in a suitablynoticeable and visible location.

To reduce or prevent opportunity for substantial retaining absorption ofthe urine, it may be desired that the liquid control structure 15 notcontain a substantial quantity of water-absorbent material of the typestypically used in absorbent storage layers of disposable diapers,disposable absorbent pants and other absorbent personal hygieneproducts, i.e., cellulose fibers; cotton fibers, other plant fibers,absorbent sponge; absorbent foam; superabsorbent polymer; absorbentgelling material; hydrogel-forming particles; and/or absorbent polymerparticles collectively herein, “absorbent material”. (The term“absorbent material” as used herein is not intended to include materialsnot listed in the preceding sentence.) Thus, it may be desired that thevolume of the liquid control structure coextensive with at least 50percent of the plan surface area of the liquid control structurecontains no more than 50 percent, more preferably no more than 35percent, even more preferably no more than 20 percent, or 10 percent, or5 percent and still more preferably no more than an insubstantialquantity or even about 0 percent, by weight absorbent material. It maybe even further preferred that the volume of the liquid controlstructure coextensive with at least 65 percent, or 80 percent, 90percent, 95 percent or even substantially all of the plan surface areaof the liquid control structure contains no more than 50 percent, morepreferably no more than 35 percent, even more preferably no more than 20percent, or 10 percent, or 5 percent and still more preferably no morethan an insubstantial quantity or even about 0 percent, by weightabsorbent material.

It may be appreciated that the liquid control structure 15, and moreparticularly the urine capture layer 34 a, may be formed of a variety ofmaterials in a variety of sizes and/or shapes that can serve functionsof a urine capture layer identified above, while avoiding stubbornlyretaining absorption of urine. Accordingly, when use for obtaining aurine sample is a primary purpose of the diaper 10, it may be desiredthat the product have an average Liquid Release Ratio of at least 3percent, more preferably at least 5 percent, even more preferably atleast 15 percent, 25 percent, 35 percent, 45 percent, and still morepreferably at least 50 percent, as measured by the Liquid Release RatioTest Method described below. Providing a diaper product having storagespace for urine provided by an envelope structure and a urine capturelayer, but having limited absorption tendency, ensures that asubstantial portion of urine deposited in such diaper by the wearer isrecoverable by the caregiver for sampling purposes.

For purpose of obtaining a urine sample that accurately represents theurine at the time of discharge, it may be desired that the envelopespace between the topsheet and backsheet contain no more than aninsubstantial quantity of water-soluble materials. As a reflection ofthe absence of a substantial quantity of water-soluble materials, forpurposes herein, purified water deposited into the diaper and thenemptied out of the diaper will exhibit a conductivity no greater than 1S/m (siemens/meter), more preferably no greater than 0.1 S/m, and evenmore preferably no more than 0.01 S/m, measured according to theConductivity Test specified below. Alternatively, or in combination, theemptied water will exhibit a surface tension from 20 mN/m(milli-Newton/meter) to 72 mN/m, more preferably from 30 mN/m to 72mN/m, even more preferably from 40 mN/m to 72 mN/m, and still morepreferably from 50 mN/m to 72 mN/m, measured according to the SurfaceTension Test specified below.

Waistband Member

As reflected in FIGS. 9, 10A and 12, diaper 10 may include anelasticized waistband member 28. A waistband member 28, located asshown, may be included to serve two functions: (1) when the diaper isworn, it may provide added elastic stretch to the rear waist region 11of the diaper, for enhancing fit and comfort; and (2) when the diaper isremoved for the wearer, it may draw the rear waist region proximate therear waist edge 29 laterally, in a manner that causes it to form a spoutstructure to channel urine out of the diaper at the rear. The lattereffect is schematically depicted in FIGS. 14A and 14B. In FIG. 14A, therear waist region of the diaper appears laterally extended, as it mightappear while being worn. In FIG. 14B, the rear waist region of thediaper appears laterally contracted such the topsheet and backsheet forma spout structure 33. The utility of spout structure 33 will be furtherexplained below.

Waistband member 28 may be disposed in the rear waist region 11 of thediaper, over the topsheet 16. However, it may also be disposed in thefront waist region 12. It may be formed of any suitable web material. Inone example, it may be formed of a nonwoven web material.

Waistband member 28 may be affixed to the diaper structure by mechanicalor thermal bonding, by adhesive or other means, or a combinationthereof. As may be appreciated from FIG. 14B, it may be affixed only atits laterally outboard portions 30, such that upon lateral contractionof waistband member 28, the sides of the rear waist portion of thediaper are drawn laterally inboard toward the longitudinal axis 12-12.The can cause the remaining diaper structure, such as topsheet 16 andbacksheet 14, to displace to form spout structure 33.

As suggested in FIG. 10A, waistband member 28 may include one or morewaistband elastic members 31. In a manner similar to inclusion oflongitudinal cuff elastic members 19, during manufacturing, waistbandelastic members 31 may be incorporated and affixed into the waistbandmember 28 structure in a pre-strained condition. Waistband member 28 maybe affixed to the diaper structure by mechanical or thermal bonding, byadhesive or other means, or a combination thereof. As may be appreciatedfrom FIG. 14B, it may be affixed only at its laterally outboard portions30, such that upon lateral contraction of waistband member 28, the sidesof the rear waist portion of the diaper are drawn laterally inboardtoward the longitudinal axis 12-12. The can cause the remaining diaperstructure, such as topsheet 16 and backsheet 14, to displace in az-direction and form spout structure 33. This may be appreciated bycomparison of FIGS. 14A and 14B.

When a diaper having a spout structure as described, and containing aquantity of urine following a discharge, is removed from awearer-patient and tilted, wearer-facing surface up, toward the spoutstructure, the urine will tend to flow by gravity into the spoutstructure. This concentrates the exiting flow of the urine past thewaist edge and facilitates neat pouring of the urine into a samplecontainer.

Urine Outlet

When the topsheet 16 selected for diaper 10 is highly or effectivelyliquid permeable for flow therethrough in both directions, it may beunnecessary to include any supplementary features to facilitate releaseof captured urine from the front or rear waist region of the diaper viatilting with or without compression, as described herein. However, FIGS.17A and 17B illustrate additional features that may be included tofacilitate the release of urine from the diaper, for sample collection.An outlet 35 may be cut, punched or otherwise formed in either or bothof topsheet 16 and backsheet 14, in either or both of front waist region12 and rear waist region 11, which can function to allow urine containedin the envelope space between the topsheet and backsheet to more easilyand neatly be poured out of the diaper. As reflected in FIG. 17B, anoutlet 35 may be accompanied by a removable or liftable outlet cover 55.Outlet cover 55 may be suitable configured to effectively prevent flowof urine out of outlet 35 until cover 55 is lifted away from the outlet35 by the user. In one example, outlet cover 55 may be a sticker formedof liquid impermeable material, covering outlet 35 and affixed to thesurrounding surfaces by adhesive. An outlet 35 may be provided incombination with the above-described spout structure 33; in one example,an outlet 35 may be located on the spout structure 33.

Packaging Configuration and Information

It may be desirable to provide a separate package for each individualdiaper. A diaper as described herein may be deemed a product for medicaluse or treatment. Thus, individual packaging of each diaper may bedesirable for purposes of actually or perceivably maintaining a level ofsterility, cleanliness, purity and structural integrity of eachindividual diaper until use, in a manner similar to the manner in which,e.g., individual bandages are packaged. A supply of individuallypackaged diapers may be packaged as a group in a larger outer package.

As noted previously, in the event that a composition, for example, awater-soluble surfactant, is included in or on materials within theenvelope space between the topsheet and backsheet, it may be desirableto include information with the packaging associated with the diaper, oreven on the diaper itself, effective to notify health care and/oranalytical personnel of the inclusion of the composition in the diaper.Other information useful for enabling health care and/or analyticalpersonnel to identify, quantify or isolate components or attributes ofthe urine recovered from the diaper may also be included with thepackaging. In one additional non-limiting example, the weight of theindividual diaper may be recorded on the diaper, the packaging or onmaterial(s) included/associated with the packaging. This will enable thecaregiver to calculate the quantity by weight of urine discharged by thepatient, from, e.g., the weight of the diaper prior to use, and themeasured weight of the diaper after its removal from the wearerfollowing a discharge of urine, prior to taking of a urine sample fromthe diaper. In one example, such information may be printed on thediaper itself, such as on an outward-facing surface of the backsheet ora visible layer thereof.

It may also be desirable to include information and/or indiciaassociated with the diaper, individual packaging (if included) or outerpackaging, identifying the diaper as a special-use diaper, anddistinguishing it from ordinary diapers. This will serve to notifyhealthcare professionals or other caregivers of the special design ofthe diaper, and help avoid confusion, inappropriate use of thespecial-use diaper for ordinary purposes, and intermixing of supplies ofthe special-use diapers with supplies of ordinary diapers.

Non-Invasive Method for Obtaining a Urine Sample from an Infant

Utilizing a suitable example of a diaper 10 as described herein, acaregiver may obtain a sample of urine from an infant patient by thefollowing steps:

-   -   Applying a diaper to a patient-wearer in substantially the same        manner as one would apply an ordinary disposable diaper;    -   Detecting a discharge of urine by the patient-wearer; this may        include observing the patient-wearer for facial, audible or        body-language signals that he or she has urinated; feeling the        diaper to detect the presence of urine; or observing a change in        appearance of the diaper resulting from the visible presence or        urine or activation of a wetness indicator included with the        diaper;    -   Removing the diaper from the patient-wearer;    -   Locating the diaper over or proximate to a sample container;    -   Tilting the diaper such that one of the front waist region and        the rear waist region is lower than the other, which orientation        may be selected according to, for example, the location of an        outlet and/or a spout structure in the front waist region or the        rear waist region; and    -   Pouring urine contained in the diaper from the lower of the        front waist region and the rear waist region, into the sample        container.    -   In some examples, the caregiver may incorporate the step of        compressing the diaper, by wringing the diaper, rolling the        diaper or otherwise, before, during or after the tilting step,        to facilitate expulsion of urine from the envelope space in the        diaper and thereby urge it out of the diaper.    -   Optionally, a step of creating a urine outlet opening in the        envelope structure of the diaper to facilitate release of urine,        following the removing step, may be included. The step may        involve cutting such an opening in the structure using a cutting        instrument, or alternatively, lifting a cover 55 from a urine        outlet 35 already included on the diaper, as described above.

The above-described method, employing any example of a diaper describedherein, may provide improved facilitation in obtaining a urine samplefrom an infant, without the need for invasive devices or techniques, orthe application of an adhesive to the infant's skin.

The diapers contemplated herein may find utility, in some examples, incircumstances involving medical diagnosis, medical treatment and/ormedical research involving very young, small and/or prematurely-borninfants. As such, it may be desired to combine any of the featuresdescribed herein with features described in U.S. application Ser. No.15/234,540, or in the application filed on the same day as the filinghereof, under attorney docket number 14880P, by Tally, et al., entitledCONFIGURABLE ABSORBENT ARTICLES HAVING IMPROVED BODILY EXUDATESEPARATION AND SAMPLING.

Liquid Release Ratio Test Method

The Liquid Release Ratio Test Method measures the volume of salinesolution that can be drained from a diaper after loading it with a knownvolume of saline solution.

Begin by removing the individual diaper samples from any packaging, andallow them to precondition at 25° C.±2 C.° and 50%±2% relative humidityfor 2 hours prior to testing. Testing is performed under these sameconditions. Following preconditioning, each diaper is tested as follows.Saline solution or water used for testing also should be at atemperature of 25° C.±2 C.°.

1. Provide a calibrated graduated cylinder capable of measuring liquidvolume contained therein to the nearest 1.0 mL.

2. Provide a rectangular sheet of rigid, nonabsorbent material having aflat surface (for example, a 5 mm thick LEXAN or PLEXIGLAS sheet), of asize at least as large in both dimensions in the x-y plane, as thediaper samples to be tested, in fully extended configuration.

3. Extend the diaper sample to its full dimensions along both directionsin the x-y plane and affix it to the sheet, with the rear waist edge ofthe diaper aligned with an edge of the sheet. The diaper can be affixedto the sheet using Velcro hook-and-loop material, tape, clamps or anyother device effective to grip or attach to the diaper along its edges,and fix the diaper in place on the sheet in its extended configuration.Do not apply any affixing devices directly over or under the liquidcontrol structure.

4. If the diaper has a topsheet overlying the liquid control structure,cut a neat 1-cm square hole in the topsheet, at the rearwardmost extentof the envelope space containing the liquid control structure, withopposing corners aligned with and sides oriented diagonally to (at45-degree angles with) the longitudinal axis of the diaper. This is toprovide an outlet for draining liquid, in the draining step below.

5. Lay the sheet with the affixed diaper, wearing-facing surface up, ona horizontal work table. Locate a receiving point on the topsheet, alongthe longitudinal axis of the diaper, and 100 mm from the front waistedge.

6. Pour 30 mL of 0.9% saline solution (NaCl+deionized water) in a singlefocused stream from an approximate height of 1 inch above the topsheet,onto the receiving point, at a rate no greater than 10 mL/sec and noless than 20 mL/sec.

7. Let the diaper rest for 60 seconds following delivery of all 30 mL ofthe saline solution to the diaper.

8. Immediately after the resting period, move the edge of the sheetadjacent the diaper rear waist edge, to the edge of the table. Locatethe graduated cylinder below the edge of the table in a positionsuitable to receive liquid drained from the diaper, and lift the edge ofthe sheet adjacent the front waist edge of the diaper (which is stillaffixed to the sheet) so that the sheet and the diaper are tilted, frontwaist edge up, at an angle 45 degrees from horizontal. Allow liquid todrain from the diaper into the cylinder, for 60 seconds after tilting.(If necessary, a plastic funnel may be used to direct the liquid intothe cylinder and ensure that none is spilled.)

9. Record the volume of liquid collected in the cylinder, to the nearestmL.

Calculate the liquid release ratio for the sample as the volume ofsaline solution drained from the diaper, divided by 30 mL, andmultiplying by 100%.

Repeat this procedure for 10 diaper samples. Calculate the averageLiquid Release Ratio exhibited by the 10 samples and report the value tothe nearest 0.1%.

Conductivity Test Method

To obtain the test samples, follow all steps of the Liquid Release RatioTest Method, above, except substitute Type 1 reagent grade water forsaline solution, in Step 6. Step 9 (volume measurement), and the liquidrelease ratio calculation, are not required.

Ensure that the liquid sample drained from the diaper is at atemperature of 25° C. Measure the conductivity of a sample obtained fromeach of 10 diaper samples, and record and calculate the average of theresults. Conductivity may be measured using any suitable device adaptedfor this purpose, and adapted for testing for values within the rangesset forth in the specification above, for example, a conductivity meteravailable from Myron L Company, Carlsbad, Calif.

Surface Tension Test Method

To obtain the test samples, follow all steps of the Liquid Release RatioTest Method, above, except substitute Type 1 reagent grade water forsaline solution, in Step 6. Step 9 (volume measurement), and the liquidrelease ratio calculation, are not required.

Ensure that the liquid sample drained from the diaper is at atemperature of 25° C. Measure the surface tension of a sample obtainedfrom each of 10 diaper samples, and record and calculate the average ofthe results. Surface tension may be measured using any suitable deviceadapted for this purpose, and adapted for testing for values within theranges set forth in the specification above, for example, a surfacetensiometer available from Kibron Inc., Helsinki, Finland.

Opacity Test Method

The opacity of a backsheet material or receptacle material is the degreeto which light is blocked by that material. A higher opacity valueindicates a higher degree of light block by the material. Opacity may bemeasured using a 0° illumination/45° detection, circumferential opticalgeometry, spectrophotometer with a computer interface such as theHunterLab Lab Scan XE running Universal Software (available from HunterAssociates Laboratory Inc., Reston, Va.). Instrument calibration andmeasurements are made using the standard white and black calibrationplates provided by the vendor. All testing is performed in a roommaintained at about 23±2° C. and about 50±2% relative humidity.

Configure the spectrophotometer for the XYZ color scale, D65 illuminant,10° standard observer, with UV filter set to nominal. Standardize theinstrument according to the manufacturer's procedures using the 1.20inch port size and 1.00 inch area view. After calibration, set thesoftware to the Y opacity procedure.

To obtain the specimen of a backsheet material, lay the diaper sampleflat on a bench, body facing surface downward, and measure the totallongitudinal length of the diaper. Note a site 33% of the total lengthfrom the rear waist edge of the diaper along the longitudinal axis.Carefully remove the backsheet including any and all laminate componentsthereof, from the outward-facing side of the diaper. A cryogenic spray,such as Cyto-Freeze (obtained from Control Company, Houston, Tex.), maybe used to separate the backsheet laminate from the other components ofthe diaper. Cut a piece 50.8 mm by 50.8 mm centered at the siteidentified above. A 50.8 mm by 50.8 mm specimen of a receptacle bagmaterial may be obtained by cutting the specimen away from the bagstructure. Precondition specimens at about 23° C.±2 C.° and about 50%±2%relative humidity for 2 hours prior to testing.

Place the specimen over the measurement port. The specimen shouldcompletely cover the port with the surface corresponding to thegarment-facing surface of the diaper directed toward the port. Cover thespecimen with the white standard plate. Take a reading, then remove thewhite tile and replace it with black standard tile without moving thespecimen. Obtain a second reading, and calculate the opacity as follows:

Opacity=Y value (black backing)/Y value (white backing)×100

A total of 10 identical diapers are analyzed and their opacity resultsrecorded. Calculate and report the average opacity and standarddeviation for the 10 backsheet laminate measurements to the nearest0.01%.

The dimensions and values disclosed herein are not to be understood asbeing strictly limited to the exact numerical values recited. Instead,unless otherwise specified, each such dimension is intended to mean boththe recited value and a functionally equivalent range surrounding thatvalue.

Every document cited herein, including any cross referenced or relatedpatent or application, is hereby incorporated herein by reference in itsentirety unless expressly excluded or otherwise limited. The citation ofany document is not an admission that it is prior art with respect toany invention disclosed or claimed herein or that it alone, or in anycombination with any other reference or references, teaches, suggests ordiscloses any such invention. Further, to the extent that any meaning ordefinition of a term in this document conflicts with any meaning ordefinition of the same term in a document incorporated by reference, themeaning or definition assigned to that term in this document shallgovern.

While particular embodiments of the present disclosure have beenillustrated and described, it would be obvious to those skilled in theart that various other changes and modifications can be made withoutdeparting from the spirit and scope of the present disclosure. It istherefore intended to cover in the appended claims all such changes andmodifications that are within the scope of the present disclosure.

What is claimed is:
 1. A disposable diaper having a length, a frontportion, a rear portion, and a perineal portion between the front andrear portions, the diaper comprising: a backsheet comprising aneffectively liquid impermeable material; a transverse perineal barrierin the perineal portion comprising an effectively liquid impermeablematerial and having a proximal portion directly or indirectly overlyingthe backsheet and sealingly connected to any other component of thediaper, and a free distal edge; and a liquid control structure disposedover the backsheet and forward of the transverse perineal barrier. 2.The diaper of claim 1, comprising a front upper layer comprising aneffectively liquid permeable material, overlying the liquid controlstructure in the front portion.
 3. The diaper of claim 1, comprisingleft and right standing longitudinal cuffs each extending from the frontportion to the rear portion and having a proximal cuff portion, and afree longitudinal cuff distal edge, each longitudinal cuff comprising alongitudinal cuff elastic member proximate the free longitudinal cuffdistal edge, the longitudinal cuff elastic member being incorporatedinto the longitudinal cuff in a pre-strained condition so as to causematerial forming the free longitudinal cuff distal edge to gather andextend toward a wearer's skin when the diaper is worn.
 4. The diaper ofclaim 3, wherein the longitudinal cuffs comprise effectively liquidimpermeable material.
 5. The diaper of claim 3, wherein the longitudinalcuffs comprise polymeric film.
 6. The diaper of claim 3, wherein thetransverse perineal barrier has left and right side edges eachrespectively attached to a left or right longitudinal cuff.
 7. Adisposable diaper having a length, a front portion, a rear portion, anda perineal portion between the front and rear portions, the disposablediaper comprising: a backsheet comprising an effectively liquidimpermeable material; a liquid control structure disposed over thebacksheet and extending from the front portion to the rear portion; arear upper layer comprising an effectively liquid impermeable material,overlying the liquid control structure in the rear portion; and atransverse perineal barrier in the perineal portion comprising aneffectively liquid impermeable material and having a proximal portiondirectly or indirectly overlying the backsheet and directly orindirectly sealingly connected to any other component of the diaper, anda free distal edge.
 8. The diaper of claim 7, wherein the rear upperlayer comprises polymeric film.
 9. The diaper of claim 7, comprising afront upper layer comprising an effectively liquid permeable material,overlying the liquid control structure in the front portion.
 10. Thediaper of claim 9, wherein the front upper layer and the rear upperlayer are formed at least in part of a common section of material. 11.The diaper of claim 7, wherein the rear upper layer and the transverseperineal barrier are formed at least in part of a common section ofmaterial.
 12. The diaper of claim 7, comprising left and right standinglongitudinal cuffs each extending from the front portion to the rearportion and having a proximal cuff portion, and a free longitudinal cuffdistal edge, each longitudinal cuff comprising a longitudinal cuffelastic member proximate the free longitudinal cuff distal edge, thelongitudinal cuff elastic member being incorporated into thelongitudinal cuff in a pre-strained condition so as to cause materialforming the free longitudinal cuff distal edge to gather and extendtoward a wearer's skin when the diaper is worn.
 13. The diaper of claim12, wherein the longitudinal cuffs comprise effectively liquidimpermeable material.
 14. The diaper of claim 12, wherein thelongitudinal cuffs comprise polymeric film.
 15. The diaper of claim 12,wherein the transverse perineal barrier has left and right side edgeseach respectively attached to a left or right longitudinal cuff.